Field of the Invention
The present invention relates to a device that can be inserted into a body through a natural orifice with an endoscope or other steerable guide member. The present invention may be used in conjunction with a suturing instrument to secure an applied suture to the tissue of a mammal, whether human or not, and whether or not alive.
State of the Art
Natural orifice surgery involves passing surgical instruments in association with an endoscopic camera through a natural orifice, such as the mouth, vagina, or anus, to a desired organ. By avoiding major incisions through the skin, muscle, and nerves of the abdomen, patients may experience a quicker recovery with less pain and scarring while further reducing the post-operative risk of surgery.
In co-owned US Pub. Nos. 20090312775A1 and 20120157765, endoscopic suturing devices suitable for use in a natural orifice procedure are described. The devices described each have a structure with a sufficiently small distal profile for delivery through a natural orifice, while providing a needle movable on an arm through a large opening and closing angle and which produces a large force upon the needle for piercing tissue to perform a surgical operation such as tissue approximation and suturing. A length of suture is permanently attached to the needle and forms stitches about tissue engaged at the distal end of the device as the needle is moved through the tissue and the distal end of the device is moved relative to the tissue. After one or more stitches have been formed in the tissue, the needle is released from the device and the free end of the suture is secured relative to the tissue. In accord with one manner of securing the free end of the suture, portions of the suture may be tied together about the tissue. In accord with another manner of securing the suture, a cinch element is advanced over the suture and cinches the tissue between the needle on one side of the tissue and the cinch on the other side of the tissue.
In addition to the cinch and cinch-applying instrument described in the above-referenced publication, other cinch instruments and deployable cinches are known. For example, referring to prior art FIG. 1, also known is a cinch applicator 910 for use in deploying the two parts 912, 914 of a cinch onto suture 916 in a surgical procedure. The applicator 910 includes an elongate flexible tubular member 918, a hypotube 920 fixed to the distal end 922 of the flexible tubular member 918, a flexible shaft 924 extending through the tubular member 918 and the hypotube 920, and a proximal handle (not shown) for moving the shaft 924 longitudinally relative to the tubular member 918. The hypotube 920 defines a distal housing 926 and a proximal lateral window 928. A slidable plunger 930 formed with a guillotine 932 is provided within the hypotube 920, with the guillotine 932 fully proximal of the housing 926 and distal of the lateral window 928.
The two-part cinch includes a collar 912, and a plug 914 engageable within the collar. The collar 912 has a cylindrical outer shape that is retained in the distal housing 926 of the hypotube 920 with a simple dimpling mating structure. The collar 912 also includes a proximal inner lip 933, and an outer lip 934 seating at the distal end of the hypotube 920 and having a flat distal facing end 935. The plug 914 of the cinch is attached to the distal end of the flexible shaft 924. The plug 914 has an enlarged distal flange 936 corresponding in size and shape to the outer lip 934 on the collar 912. The plug 914 has an elongate tubular body 938 defining a throughbore 940 in which the flexible shaft 924 extends, and a proximal circumferential exterior groove 942. A distal portion of the shaft 924 has a bend 944 to facilitate retention within the throughbore 940. The distal end of the shaft 924 has a rounded bead 946 that sits at the flange 936 of the plug. The bend 944 and the bead 946 trap the flexible shaft relative to the plug.
In operation, from outside the patient, the proximal end of the suture 916 is thread through the collar 912 and hypotube 920 and out of the lateral window 928. Then the applicator 910 is advanced through an endoscope so that the elements of the cinch are provided adjacent the stitched tissue. When the handle is operated, the shaft 924 is retracted to draw the plug 914 into an interference fit within the collar 912, with the inner lip 933 of the collar positively engaging the outer groove 942 on the plug. The suture 916 is captured between the outer surface of the plug 914 and the inner surface of the collar 912 so that the cinch is secured to the suture. Upon further retraction of the shaft 924, the shaft is pulled such that the bend 944 and bead 946 of the shaft 924 are pulled all the way through the plug 914 until released therefrom, and drawn back into engagement with the plunger 930. As the shaft 924 is moved further proximally relative to the hypotube 920, movement of the shaft 924 causes the guillotine 932 to slide past the window 928 and sever the proximal portion of the suture 916 from the portion of the suture attached to the cinch. Once the suture 916 is severed, a jerking motion is applied to the applicator 910 to release the engagement formed by the dimpling structure between to the cinch 912, 914 and applicator 910.
The applicator and cinch are thereby together capable of effectively securing stitched suture to tissue. Once the cinch 912, 914 is secured to the suture, the applicator 910 is no longer capable of securing another cinch on another area of suture, as the bend 944 and bead 946 of the shaft 924 cannot be inserted through another plug during the procedure; the shaft is intended to be proximally loaded through the plug. Thus, the applicator is a single-use device.